Medical ablation devices and methods

ABSTRACT

Ablation devices, more specifically needle injectors configured to deliver flowable thermal treatment media into an interface with tissue and that can provide a single dose of ablative energy.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.16/407,010, filed May 8, 2019, which claims benefit of priority to U.S.provisional application No. 62/668,815 filed May 9, 2018, the entiretyof each of which is incorporated by reference herein.

BACKGROUND OF THE INVENTION 1. Field of the Invention

This invention relates to tissue ablation devices, and more specificallyrelates to needle injectors that are configured to deliver flowablethermal treatment media into an interface with tissue and that canprovide a single dose of ablative energy.

2. Description of the Background Art

Many types of ablation systems and devices have been developed fordelivering thermal energy to tissue, including radiofrequency (RF)devices, laser devices, microwave devices, resistive heating devices andthe like. Typically, such energy delivery systems are complex andrequire expensive generators and control systems.

What is needed for many ablation procedures is a system that cancontrollably deliver precise, limited amounts of energy to tissue forpurposes of localized ablations, for example to ablate nerves, vascularmalformations, tumors, warts, scar tissue, hypertrophic or hyperplastictissue and the like.

SUMMARY OF THE INVENTION

The present invention relates to tissue ablation devices and relatedmethods of use. Variations of the invention will now be described toprovide an overall understanding of the principles of the form, functionand methods of use of the systems disclosed herein. In general, thepresent invention provides devices or injectors that are configured toapply or inject a pre-set amount of ablative energy into tissue,typically interstitially but variations of this disclosure includeenergy delivery applied in any manner based on the application,including but not limited to an intraluminal treatment or a topicaltreatment. A variation of the devices described herein can comprisesingle-use devices. Some aspects of the devices (also referred to as“ablation sticks”) includes (i) delivery of a selected total amount ofenergy over a selected brief time interval, and (ii) delivery of aselected energy dose at a predetermined rate, e.g., in calories/sec,over a multi-second interval. This description of the general principlesof the invention is not to limit the inventive concepts in the appendedclaims. In addition, one application of the systems described hereinincludes ablation of tissue. However, in many cases the devices andmethods can apply for coagulative, or therapeutic modes of energydelivery that do not result in ablation of tissue.

In one example, systems described herein include one or more single-use,inexpensive, disposable probes that have a rigid or flexible bodyextending to a distal needle portion wherein an interior chamber in theprobe body contains subcritical water as a thermal flow media fortreating tissue. The probe body includes a release mechanism allowingthe thermal flow media to flow through the needle portion to interfacewith the targeted tissue. The probe or “ablation stick” can be connectedto an energy source, such as a battery, which is configured to energizea heating mechanism in the probe body to provide subcritical water inthe interior chamber.

In a first variation, a probe can be configured as a single-usedisposable probe with a sealed interior chamber having a predeterminedfluid volume configured to provide a predetermined energy dose. Forexample, in such a variation the interior chamber can have a volumeranging between 0.005 ml and 5.0 ml or more often between 0.010 ml and2.0 ml. Variations of the devices can include the predetermined energydoses of at least 10 calories. Alternate variations can include thetotal energy dose is between 10 cal. and 1,000 cal.

In another aspect, a probe or ablation stick is configured fordelivering a predetermined energy dose at a rate ranging between 1cal/sec and 200 cal/sec, and often at a rate ranging between 5 cal/secand 100 cal/sec.

Variations of the devices and methods include a heat transfer mechanism,which provides flow media in the interior chamber having a fluidpressure of at least 1.5 bar and often at least 2 bar or at least 5 bar.In some variations, such fluid pressure is at least 10 bar and the flowmedia can have a corresponding temperature of at least 110° C., andoften at least 120° C. or at least 140° C.

The devices and methods can also include release mechanisms that releaseflow media from the interior chamber. Such mechanisms can include aninstant release mechanism. Additional variations can include asingle-use rupture disc or a magnetically-responsive pressure reliefvalve. Alternatively, or in combination, the release mechanism cancomprise a valve adapted to pulse the release of thermal flow media.

In additional variations, the probe carries a needle that has an initialnon-extended position and is ballistically extendable to an extendedposition by fluid pressure from the interior chamber.

Variations of the probes described herein can include a source forproviding a thermal fluid media from a source that is less than 10 cmfrom an outflow aperture in the working end.

In additional embodiments, ablations sticks can be integrated into asystem that includes (i) a flexible or rigid endoscope with a distalimaging sensor, wherein the endoscope is less than 6 mm in diameter andmore often less than 5 mm in diameter, (ii) an articulating sleeveassembly that can be introduced through or integrated into theendoscope, and (iii) a kit of one or more flexible ablation sticks forthe delivery of one or more preset energy doses. In this systemembodiment, the endoscope can be navigated through a body lumen orpassageway to reach a targeted site, and thereafter the articulatingassembly can be manipulated to introduce a needle portion of theablation stick at any angle into targeted tissue for a subsequentablation.

An additional variation of a probe carries a fluid-filled chamberproximate to the needle assembly wherein an energy source coupled withfluid in the chamber can be explosively vaporized to ballistically movethe needle assembly from a non-extended position to an extendedposition. Additionally, the energy source that is utilized toballistically drive a needle assembly from a non-extended position to anextended position can be controlled to provide a plurality of selectedenergy delivery levels to thereby allow different rates of the needleacceleration to penetrate different needles in different tissues.

Additional advantages of the invention will be apparent from thefollowing description, the accompanying drawings and the appendedclaims.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the present invention will be discussed withreference to the appended drawings. These drawings depict onlyillustrative embodiments of the invention and are not to be consideredlimiting of its scope.

FIG. 1A is an illustration of a method of the invention for treatingdeep wrinkles in a patient's forehead by introducing a needle tip of adevice into a targeted site and thereafter ejecting subcritical waterfrom an interior chamber in the device to provide a flow through anaperture in the needle tip to ablate targeted nerves.

FIG. 1B is a schematic illustration of a method as in FIG. 1A whereinthe device handle is shown and the needle tip is introduced into thesite proximate targeted nerves.

FIG. 2 is a schematic view of a device as in FIG. 1A-1B which includes abody portion having an interior chamber configured for containingsubcritical water and a valve or release mechanism for releasing thesubcritical water from the interior chamber into a flow passageway toprovide a fluid flow through a distal aperture, and further illustratingan energy source for heating the contents of the interior chamber.

FIG. 3A is perspective view of a release mechanism for releasing thesubcritical water from the interior chamber which comprising a rupturedisc in an initial, non-ruptured configuration that seals the interiorchamber.

FIG. 3B is a view of the rupture disc of FIG. 3A in a secondary,ruptured configuration for releasing subcritical water from the interiorchamber.

FIG. 4A is a sectional view another variation of a device similar tothat FIG. 2 in a first configuration which includes a body portionhaving a cartridge with an interior chamber configured for containingsubcritical water, a release mechanism for releasing the subcriticalwater from the interior chamber wherein the release mechanism comprisesa squeeze valve shown in a valve-closed position that can be actuated toopen by application of energy from an electrical source and furtherillustrating a resistive heating mechanism for heating the fluidcontents of the interior chamber.

FIG. 4B is a sectional view of device of FIG. 4A in a secondconfiguration wherein the squeeze valve is shown in a valve-openposition.

FIG. 4C is a perspective view of the squeeze valve of FIGS. 4A-4Bseparated from the device body.

FIG. 5 is another variation of a probe similar to that of FIGS. 4A-4B,with a sectional view of an interior chamber configured for containingsubcritical water, a shape memory alloy valve mechanism for releasingsubcritical water from the interior chamber and an inductive heatingmechanism for providing subcritical water.

FIG. 6A is an enlarged sectional view of the valve mechanism of FIG. 5in a valve-closed position.

FIG. 6B is a sectional view of the valve mechanism of FIG. 6A in avalve-open position.

FIG. 7 is a schematic cut-away view of a method of using the probe ofFIG. 5 to ablate abnormal tissue in a patient's stomach wall.

FIG. 8 is a sectional schematic view of the needle portion of the probeof FIG. 5 illustrating the release of subcritical water from an interiorchamber to provide a flow into and through a flow passageway andapertures to interface with tissue.

FIG. 9 is a sectional view of another variation of a probe similar tothat of FIG. 5 with an interior chamber that is flexible.

FIG. 10A is a sectional view of a working end of another variation of aprobe similar to that of FIGS. 5 and 9 illustrating a different valvemechanism in a valve-closed position.

FIG. 10B is a sectional view of the valve mechanism of FIG. 10A in avalve-open position.

FIG. 11 is a sectional view of a working of another variation of a probesimilar to that of FIGS. 10A-10B illustrating a different valvemechanism that is configured for pulsing the release of subcriticalwater from an interior chamber in a device body.

FIG. 12 is a schematic section view of a method of using a probe as inFIGS. 4A, 5, 10A or 11 to treat a patient's hemorrhoid.

FIG. 13 is a schematic section view of a method of using a probe as inFIGS. 4A, 5, 10A or 11 to treat a keloid in a patient's skin.

FIG. 14 is a schematic illustration of another probe with a working endthat carries a plurality interior chambers configured to carrysubcritical water and an independent valve mechanism for each interiorchamber.

FIG. 15 is a schematic view of a method of using a probe as in FIGS. 4A,5, 10A or 11 to treat abnormal tissue in a patient's lung, such as anodule or tumor.

FIG. 16A is a sectional view of a working end of another ablation probewith a needle member that is ballistically extendable from the devicebody, showing the needle member in an initial non-extended position.

FIG. 16B is another sectional view of the working end of FIG. 16Ashowing the needle member in an extended position.

FIG. 17A is a sectional view of another variation of a release mechanismthat comprises a magnetically-controlled pressure relief valve shown ina valve-closed position.

FIG. 17B a sectional view of the magnetically-controlled pressure reliefvalve of FIG. 17A shown in a valve-open position.

FIG. 18 is a sectional view of another variation of amagnetically-controlled pressure relief valve in a valve-closedposition.

FIG. 19A is a cut-away view of a working end of an integrated ablationsystem including an endoscope component with a distal imaging sensor,and articulating sleeve component and a flexible ablation catheter orprobe similar to that of FIGS. 14 and 16A, with the needle portion in anon-extended position.

FIG. 19B is another view of the working end of the system of FIG. 19Awith the needle portion in an extended position.

FIGS. 20A-20C illustrate individual functional components and sterilepackaging of a treatment kit corresponding to the invention wherein thekey functional components at separate rather than integrated asdescribed in previous variations, wherein FIG. 20A illustrates anelongated flexible endoscope component, FIG. 20B illustrates anelongated catheter with a distal articulating region for introducingthrough a working channel of the endoscope component of FIG. 20A, andFIG. 20C illustrates an elongated ablation probe with an extendableneedle portion, wherein the probe adapted for introduction through thearticulating catheter component of FIG. 20B.

FIGS. 21A-21C illustrates individual functional components of atreatment kit similar to that of FIGS. 20A-20C, wherein FIG. 21Aillustrates an endoscope component that consists of a relatively short,rigid member rather than an elongated flexible member as in FIG. 20A,FIG. 21B depicts an articulating sleeve component, and FIG. 21Cillustrates an ablation probe.

FIG. 22A is a view of the working end of another probe variation with adistal needle portion in a non-extended position as described previouslywith a fluid-filled chamber and electrode arrangement adapted forballistic advancement of the needle from a non-extended position to anextended position and wherein a controller can vary the power leveldelivered to the electrode arrangement to provide a plurality of needleacceleration rates.

FIG. 22B illustrates the needle of FIG. 22A in an extended positionfollowing the explosive vaporization of fluid in the fluid-filledchamber to move the needle from the non-extended position to theextended position.

FIG. 23A is a view of the working end of another probe similar to thatof FIG. 21A with a distal needle in a non-extended position in a springmechanism adapted for advancing the needle two and extended positionfrom the non-extended position together with an adjustment mechanismthat can adjust the spring mechanism to provide a plurality of needleacceleration rates.

FIG. 23B illustrates the needle of FIG. 23A in an extended positionfollowing the release of a walking mechanism that allows the springmechanism to move the needle from the non-extended position to theextended position.

FIG. 24 is a schematic view of another system variation that includes anablation stick and endoscope where the ablation stick again has aninterior chamber configured for containing subcritical water, a valvemechanism for releasing subcritical water from the interior chamber toprovide a media flow through a flow outlet in a needle member as inprevious embodiments, and further includes a second energy sourcecoupled to an electrode arrangement adapted to ionize the media flowfrom the flow outlet to enhance energy delivery to ablate targetedtissue.

FIG. 25A is an enlarged view of the distal region of the ablation stickof FIG. 24 showing the interior chamber, the valve, and a flexiblepolymer needle member.

FIG. 25B is an enlarged sectional view of the distal region of theablation stick of FIG. 25B showing the interior chamber, temperaturesensors coupled to the interior chamber, the valve, and a electrodearrangement carried at the distal end of the needle member.

FIG. 26A is a further enlarged view of the distal and of the needlemember showing a first electrode.

FIG. 26B is a sectional view of the distal and of the needle member FIG.26A showing the first and second electrodes carried by the needle tip.

FIG. 27 is a schematic view the needle tip of FIG. 20 6B in tissueillustrating a flow of subcritical media through the needle member andenergy being delivered from electrode arrangement to ionize the mediaflow outwardly from the flow outlet.

FIG. 28A is an illustration of another variation of ablation stick thatis similar to the embodiment shown in FIG. 24 except that the ablationstick further includes a spring mechanism for advancing the needlemember into tissue upon release of a lock-release mechanism with aneedle member is in a cocked position.

FIG. 28B is another variation view of the ablation stick of FIG. 28Aafter actuation of the lock-release mechanism to thereby allow thisspring to advance the needle member in the distal direction.

FIG. 29A is an enlarged view of the central portion of the ablationstick of FIG. 28A showing the spring in a cocked position.

FIG. 29B is an enlarged view of the central portion of the ablationstick of FIG. 28B after actuation of the lock-release mechanism andrelease of the spring to advance the needle member in the distaldirection.

FIG. 30A is an illustration of the ablation stick of FIG. 28A latched toan endoscope with the needle member in a retracted, cocked position.

FIG. 30B is an illustration of the ablation stick and endoscope of FIG.30A with the needle member in a released extended position.

FIG. 31A is an illustration of another variation of ablation stick thatis similar to the embodiment shown in FIG. 30A with a latch mechanismfor coupling the ablation stick to an endoscope.

FIG. 31B is a side view of another variation of endoscope with theablation stick of FIG. 31A coupled thereto, where the endoscope has aelongated shaft and carries a distal imaging sensor together with anextension portion with a curved needle channel for directing a flexiblepolymer needle outwardly at an angle relative to the axis of theendoscope.

FIG. 31C is another view of the endoscope of FIG. 31 B with a flexibleneedle having been actuated and extending outwardly from the curvedneedle channel.

FIG. 32 is a perspective view of the distal end of the endoscope of FIG.31B showing the imaging sensor, LEDs, the curved needle channel, aninflow channel and an outflow channel for irrigating a treatment site.

FIG. 33 is a diagram showing the method of the invention relating to theuse of the endoscope in the ablation stick of FIGS. 31A-32.

FIG. 34 is another variation of an ablation probe similar to that ofFIG. 2 that carries a battery or capacitor in a proximal shaft portionof the probe for providing subcritical liquid in an interior chamber ofthe probe.

FIG. 35 is another variation of an ablation probe similar to that ofFIG. 28A that carries first and second batteries or capacitors in aproximal portion of the probe for (i) providing subcritical liquid in aninterior chamber of the probe and (ii) providing electrical energy forionizing a media flow outward from a flow outlet in a needle member ofthe probe.

FIG. 36 is a schematic view of a base station for charging a probe ofthe types shown in FIGS. 34 and 35.

DESCRIPTION OF THE INVENTION

The present invention relates to energy delivery devices and relatedmethods of use. Variations of the invention will now be described toprovide an overall understanding of the principles of the form, functionand methods of use of the devices disclosed herein. In general, thepresent invention provides single-use devices or injectors that areconfigured to apply or inject a pre-set amount of ablative energy intotissue, typically interstitially but alternatively the energy deliverycan be an intraluminal treatment or a topical treatment. The single-usedevices or ablation sticks can be designed (i) to deliver a selectedtotal amount of energy over a selected interval, and (ii) to deliver aselected energy dose with a predetermined amount of energy per/secondover a multi-second interval. This description of the general principlesof this invention is not meant to limit the inventive concepts in theappended claims.

FIGS. 1A, 1B and 2 are illustrations of a variation of an ablationsystem 100 that is adapted for the treatment of deep wrinkles. Thesystem includes a handheld device with has a body portion 102 and adistal needle portion 105 that is introduced into at targeted site. Adistal region 118 of the body portion 102 has an interior chamber 120that carries subcritical water 122 that can be releases therefrom toflow through at least one aperture 124 in the needle portion 105 tointerface with tissue and thereby ablate targeted nerves N underlyingskin SK (see FIG. 1B). The ablation of nerves with the methodcorresponding invention to treat wrinkles is adapted to function similarto a Botox treatment. Such an ablation treatment as depicted in FIGS.1A-1B ablates nerves to block signals from the nerves which can therebyweaken facial muscles in the skin of the forehead, thus easing thetension that causes wrinkles to form. The ablation treatment of theinvention can be longer lasting than Botox and can be used for treatmentof moderate-to-severe glabellar lines (frown lines between eyebrows) andother facial creases.

FIG. 2 is a schematic view of a single-use hand-held device 100 as inFIG. 1 which shows an elongated a body or handle portion 102 extendingalong axis 128 and is coupled to distal needle portion 105. The bodyportion 102 can have any suitable cross-section dimension D for grippingwith a human hand and fingers or alternatively can be configured forcoupling to a robotic system for controlled insertion of the needleportion 105 into a patient's body. The interior chamber 120 isconfigured to carry a pressurized heated fluid, which in one variationis heated, pressurized or subcritical sterile water 122. The device 100also carries a subcritical water release mechanism 140 which can be avalve other type of release mechanism as described in more detail below.The release mechanism 140 provides a valve-closed configuration or sealto seal a flow passageway 142 extending from the interior chamber 120through the needle portion 105 to the at least one outflow aperture 124.In a variation, the release mechanism 140 is a pressure relief valve asis known in the art which opens at a predetermined pressure withinpressure ranges described in more detail below.

In a variation shown in FIGS. 3A-3B, the release mechanism 140 comprisesa rupture disc 144 in flow passageway 142 which is a non-reclosingpressure relief mechanism or valve adapted for a single use, wherein thedisc 144 in an initial form (FIG. 3A) ruptures at a selected pressure toprovide a valve-open position (FIG. 3B) to thereby release subcriticalwater from the interior chamber 120. Thus, the rupture disc 144 of FIGS.3A-3B is a sacrificial component or one-time-use membrane that fails atthe selected fluid pressure in interior chamber 120. The disc 144 can befabricated of a metal but other materials such as plastics andelastomers or layers of different materials can be used as alternatives.The rupture disc 144 provides an instant response which can occur inmilliseconds to allow release of subcritical water from interior chamber120. In FIG. 3A, it can be seen that a disc 144 has a dome region 148facing distally that comprises a metal that is weakened by precisioncuts or scores 152 in the material, for example by using lasers to etchthe scores 152 to a precise depth in the material. The rupture of disc144 about the scores 152 occurs when tensile forces exceed the ultimatetensile stress of the disc material as shown in FIG. 3B.

In a variation, referring again to FIG. 2, the interior chamber 120 hasa very limited capacity, for example, from about one-half drop of waterto 40 drops of water, or about 0.025 ml to 2 ml. More often, theinterior chamber capacity is from about 1 drop of water to 20 drops ofwater (0.05 ml, to 1.0 ml). FIG. 2 further illustrates schematicallythat an electrical source 155 is coupled to a heating mechanism 160configured to delivery energy to the interior chamber 120 to providesubcritical water 122 therein. In a variation, the device 100 with theinterior chamber 120 is pre-packaged and sealed wherein the fluidpressure may be slightly higher than ambient pressure. After applyingenergy from heating mechanism 160, the fluid pressure of subcriticalwater 122 in chamber 120 is at least 1.5 bar, at least 2 bar or at least5 bar. Often, the fluid pressure is at least 10 bar or at least 15 bar.As an example, the fluid pressure would be approximately 16 bar (232psi) at 200° C. As a comparison, at room temperature, a common CO₂canister used is some medical devices has an internal pressure of over850 psi. Typically, the single-use devices 100 corresponding to theinvention are provided with small capacity interior chambers 120 thatare adapted for higher subcritical water pressures than devices withlarger capacity interior chambers. The term subcritical water as usedherein refers to water maintained in a liquid phase (typically held bypressure) at temperatures above the atmospheric boiling point (100° C.)and up to the critical temperature (374° C.) of water. As can beunderstood, subcritical water is stable in the interior chamber 120because of the overpressure raises the boiling point. Variations of thedevices and methods described herein can include various subcriticalliquids and/or or solutions in addition to or in place of water.

It also can be understood that the amount of applied energy, for examplemeasured in calories, required to ablate nerves to subdue musclecontraction as in FIGS. 1A-1B is exceedingly small. Further, the amountof energy carried in subcritical water is very high so that the totalvolume of subcritical water released from the interior chamber 120 tothereafter interface with tissue (FIGS. 1 and 3) can be less thanone-half drop or less than one drop of subcritical water. The durationof treatment, that is, the time interval over which the subcriticalwater is interfaces with tissue after flow into at least one aperture124 in needle portion 105 may be less than one-half second, or less thanone second. Longer duration flows are described with other devicevariations and treatments below. The corresponding flow rate ofsubcritical water may be from 0.25 ml per minute to 2.5 ml per minute.All these variables are predetermined by the design of an individualdevice 100 (see FIG. 2) and the operating parameters of the heatingmechanism 160 and energy applied thereto. More in particular, devicesmay be provided in a variety of configurations which are optimized forparticular treatments. For example, a device 100 and the energy source155 coupled to interior chamber 120 can be designed to provide (i) apredetermined number of calories delivered, (ii) a predeterminedtreatment interval, and/or (iii) a predetermined flow rate through theat least one aperture in the needle portion 105. In such a variation,the flow rate of subcritical water to the needle portion 105 can bepredetermined by the dimensions of the flow passageway 142 extendingaway from the interior chamber 120 and the dimensions of at least oneoutflow aperture 124 in the needle portion 105 (see FIG. 2). It shouldbe appreciated that there may be a single outflow aperture 124 thedistal tip of the needle 105, or a plurality of outflow apertures aroundthe distal tip of the needle 105 or microporosities in a microporousneedle tip region.

In the variation shown in FIG. 2, the energy source 155 and heatingmechanism 160 can comprise any suitable system configured for rapidlyheating the fluid content of interior chamber 120 to provide subcriticalwater 122 with selected parameters therein. In FIG. 2, an actuationbutton 162 is provided to activate the heating mechanism 160. In atypical example, the heating mechanism 160 can comprise a resistiveheating element that heats a wall around interior chamber 120 or aresistive electrical element that is immersed in fluid content of theinterior chamber 120. In another variation, a coil coupled to anelectrical source can be configured for inductively heating metallicwalls of the interior chamber or inductive elements that interface withthe fluid content of the interior chamber 120. In other variations, alaser or microwave mechanism may be used to heat the fluid content ofthe interior chamber.

Still referring to the schematic illustration of FIG. 2, the needleportion 105 typically comprises a needle shaft ranging in size fromabout 18 ga to 32 ga but may range up to 14 ga. The length of the needleportion 105 can range from about 2 mm to 20 mm or more for differentapplications, but typically may be 5 mm to 15 mm. The needle typicallycan be metal but polymeric needles also may be used and can befabricated from a material such as PEEK. Ceramic microneedles are alsoknown and can be used in the needle portion 105, or needles can befabricated of a combination of a metal, polymer and/or ceramic. Often, aflexible polymeric needle may be used.

In one aspect of the invention, referring to FIG. 2, a device 100 isadapted to deliver a predetermined amount of energy dose to tissue, forexample measured in total calories, and thus an inventory of energydelivery sticks can be provided which then allows for selection of aparticular device for a particular procedure. In another aspect of theinvention, a device 100 is adapted to deliver an energy dose at apredetermined rate, for example, in calories/second over a timeinterval. Such a predetermined rate of energy delivery is provided, inpart, by selecting the dimensions of the flow channel in the needleportion 205 and the dimensions of outflow apertures in the needleportion. The rate of energy delivery is further controlled by the fluidpressure provided in the interior chamber, and the selected pressure atwhich the release mechanism releases the fluid. The rate of energydelivery through the 14 ga to 32 ga needles described above can rangefrom about 1 cal/sec to 200 cal/sec, but typically would range between 5cal/sec and 100 cal/sec.

In general, the predetermined energy dose is provided by a predeterminedfluid capacity in the interior chamber 120 which in turn determines theamount of energy, or a range of energy, that may be delivered from sucha single-use device 100. A single-use pre-packaged device 100 then candeliver a precise energy dose while eliminating the need for a controlsystem or complex controller for controlling fluid flow rates from apump, fluid pressure, constant or varied applied energy over a timeinterval, etc. It can be understood that the energy capable of beingdelivered can be calculated based on the fluid capacity in combinationwith the temperature of the subcritical water when released to flowthrough an aperture 124. Thus, for example, a physician with experiencewill become knowledgeable about the amount of applied energy that isoptimal to achieve a particular ablation treatment, for example toablate nerves, keloids, warts, skin lesions, sweat glands, hyperplasticor hypertrophic tissue, hemorrhoids, etc., and then a particularsingle-use device 100 can be selected which has the appropriate energydelivery capacity, or alternatively a plurality of devices can be usedwherein each device has an energy capacity that can be additive in thetreatment.

In one aspect, it is important to provide single-use devices 100 such asin FIGS. 2-3 that are configured with an interior chamber 120 with apredetermined fluid capacity that is quite limited, for example, lessthan 2 ml, less than 1 ml or less than 0.5 ml. As described above, theinterior chamber 120 (FIG. 2) can be under a relatively high pressure sothat there will be a possibility that the chamber 120 could rupture andrelease the pressurized fluid, which could have adverse effects on apatient or the physician. However, by design, the volume of subcriticalwater is very small so that the rupture of an interior chamber 120 thatcarries only a limited number of drops of subcritical water will not becatastrophic, while at the same the volume can carry enough for energyfor many treatments.

In general, a method of ablating tissue corresponding to the inventioncomprises introducing an injector working end with at least one outflowaperture into a targeted site in an interior of a patient's body andejecting subcritical water from an interior chamber in the injector toprovide a flow through the at least one outflow aperture to interfacewith tissue in the site thereby delivering a dose of ablative energy tothe tissue. In this method, the volume of the interior chamber isconfigured to provide a predetermined energy dose, which is greater than10 calories. In variations of the single-use device, the deliverableenergy dose can be between 10 calories and 1000 calories, and more oftenbetween 10 calories and 500 calories. In some variations, the energydose can be between 10 calories and 250 calories. In this method of theinvention, the subcritical water in the interior chamber has a volumeranging between 0.005 ml and 5.0 ml or more often between 0.010 ml and2.0 ml. Further, in this method, the subcritical water has a temperatureof at least 110° C., or at least 120° C. or at least 140° C.

In another aspect of the invention, the source of thermal fluid media orsubcritical water is within close proximity to the needle portion andoutflow aperture therein, which allows for little or no change in thetemperature of the fluid media after release from the source or interiorchamber until the flow reaches one or more outflow apertures. Forexample, in some embodiments, the source of fluid media is less 10 cmfrom an outflow aperture, and often the source is less than 5 cm from anoutflow aperture. In general, a system corresponding to the inventionfor ablating tissue in a medical treatment comprises providing a probehaving a working end adapted for introduction into a patient's body, asource carried by the probe adapted for providing a thermal fluid mediacapable of ablating tissue wherein said source is less than 10 cm anoutflow aperture in the working end, or the source is less than 5 cmfrom such an outflow aperture. In this variation, a valve mechanismagain is carried distally of the fluid media source to control fluidflow to the outflow aperture in the working end. In this variation, thefluid media source again has a fluid volume ranging between 0.005 ml and5 ml and the system includes a heating mechanism operatively coupled tothe source.

Now turning to FIGS. 4A-4C, a more detailed variation of a device 200 isshown that has an elongate device body 202 with needle portion 205extending therefrom. The device body 202 comprises a stainless steel orpolymer sleeve 206 with endcap 208 fixed thereto. Needle member 205 isfixed to and extends distally from endcap 208. In this variation, theinterior chamber 210 is within a cartridge 212 carried in the devicebody 202. The cartridge 212 is configured to contain the subcriticalwater 122 in interior chamber 210 with an outlet 214 in a neck 218 ofthe cartridge 212. The cartridge 212 can be fabricated of a suitablemetal such as stainless steel or can be a plastic material.

In the variation of FIGS. 4A-4C, the valve mechanism or subcriticalwater release mechanism comprises a form of squeeze valve 220 thatcomprises a compression-release collar 222 that squeezes a resilientelastomeric tubing 225 to provide a valve-closed position as shown inFIG. 4A. The compression-release collar 222 can be actuated to relaxcompression on the resilient tubing 225 to provide a valve-open positionas shown in FIG. 4B. Thus, the valve 220 is a single-use valve that hasan initial valve-closed position (FIG. 4A) and is openable one time tothe valve-open position (FIG. 4B).

FIG. 4C shows a perspective view of the squeeze valve 220 separated fromthe assembly of FIGS. 4A and 4B. The elastomeric tubing 225 can be abiocompatible tubing such as silicone that has sufficiently strong wallsto contain the above-described fluid pressures in the interior chamber210 and can be compressed to provide the valve-closed position of FIG.4A. The proximal end 226 a of the elastomeric tubing 225 is fixed to theneck 218 of the cartridge by adhesives and/or mechanical clamps, forexample, ring-clamp 228 a (FIG. 4A). The distal end 226 b of elastomerictubing 225 is fixed to the proximal end 230 of the needle portion 205 byadhesives and/or mechanical clamps, for example, ring-clamp 228 b (FIG.4A).

The compression-release collar 222 can be any of several types ofone-time use collars that can be expandable, meltable, frangible,sacrificial or the like and that can be actuated typically by energydelivery to release compression on the elastomeric tubing 225. In onevariation, the collar 222 can consist of a shape memory alloy core 240surrounded by a resistive heating element 245. The NiTi core 240 whichcan have a “temporary” contracted configuration as in FIG. 4A whereinenergy can be applied to the NiTi to heat the collar beyond a transitiontemperature to be altered from its temporary configuration to anexpanded “memory” configuration to thereby provide the valve-openposition of FIG. 4B. Shape memory alloy or NiTi actuators are well knownin the art, and using similar principles are known of in the form ofvalves, pin-pullers, pin-pushers, and frangibolts (see, e.g.,http://wwwainiaerospace.com/products.html). The NiTi is actuated from ittemporary shape to its memory shape by heating, which can be heatmigrating from the subcritical fluid 122 which is heated by a heatingmechanism coupled to electrical source 250A. Alternatively, as shown inFIGS. 4A-4C, the resistive heating element 245 that surrounds the NiTicore 240 is connected to an electrical source 250B, which can be thesame as electrical source 250A when used with a controller configured tocontrol energy delivery for the two different functions. Each of theelectrical sources 250A and 250B can consist of batteries to providesystem portability. The resistive heating element 245 can consist of aresistive coil, a conductive polymer or a PTCR material (positivetemperature coefficient of resistance) as is known in the art of suchheating elements.

In other variations, the compression-release collar 222 can comprise (i)a collar of a shape memory polymer actuated by heating to move from atemporary shape to a memory shape, (ii) a collar with a discontinuitytherein that has a sacrificial weld across the discontinuity of afusible conductive polymer that will burn up upon energy delivery or(iii) a polymer collar that is meltable upon heat delivery to releasecompression on the tubing 225. In another variation, a handle of thedevice can have a moveable grip or lever actuator that can be used tomechanically release the collar. In another variation, a simple pressurerelief valve can be used that opens at a predetermined pressure.

It should further be appreciated that the device body 202 and needleportion 250 can be covered with thermally insulative materials. FIGS.4A-4B show insulator layer 252 surrounding the device body 202 which canbe any suitable thickness. In particular, the needle portion 250 canhave a thin ceramic coating (not shown) which can assist in preventingheat transmission through the shaft of the needle portion. Further, theinterior chamber 210 and the flow passageway extending from the interiorchamber through the needle portion 205 can have a thermally insulativecoating, such as a ceramic to limit heat transfer from the fluid to thedevice body 202 and the body of the needle portion.

4A-4B, the heating mechanism for providing the subcritical water 122comprises a resistive wire 280 that extends in a loop portion 282through the interior chamber 210 and the liquid content of the chamber.The wire loop portion 282 can be a NiChrome wire or a similar materialknown in the art. The wire 280 passes through insulator sleeves 284 inthe wall 286 of the cartridge 212 in the case in which the cartridgebody is fabricated of a metal rather than a plastic. The electricalleads 288 a and 288 b extend from the loop portion 282 to the electricalsource 250A which can be a battery or other electrical source. Each ofthe electrical leads 288 a and 288 b has an outer insulator layer shownin phantom view at 290 a and 290 b. While the resistive wire is shownwith a loop portion 282 in FIGS. 4A and 4B, it should be appreciatedthat the resistive wire in interior chamber 210 can be coiled, looped orotherwise bent and packed to occupy a substantial space within theinterior chamber 210 to maximize the surface area of the wire relativeto the fluid volume to provide practically instant heat transfer toprovide subcritical water. Other forms of heat transfer elements besideswires also can be used such as reticulated metal structures that carrythe subcritical water in the pores or passageways therein.

Alternatively, a plurality of resistive rods or balls functioning asheat transfer elements can be packed in interior chamber 210 andconfigured for electrical or inductive heating to provide increasedsurface area of the heated elements for effective heat transfer.

FIGS. 4A-4B further show that the device 200 includes a temperaturesensor 294 that is positioned in the device body 205 proximate thecartridge 212 to thereby determine the temperature of subcritical waterin chamber 210 and to provide a signal of the temperature to acontroller 295 or to a display (not shown).

In use, for example to treat nerves as in FIGS. 1A-1B in which limitedablation energy is required, the physician can first determine theamount of energy desired for the treatment as described above. Then, thephysician can select a device 200, for example of the type shown inFIGS. 2-4A, that has an appropriate range of ablation capacity thatbrackets the targeted energy requirement. The ablation capacity of eachdevice 200 is determined by the volume of subcritical water 122 that isreleased from an interior chamber to flow to an aperture in the needleportion 210 (see FIG. 4B) and the temperature of the subcritical water.It should be appreciated that the amount of subcritical water releasedfrom chamber 210 to interface with tissue (and the correspondingablation capacity) will be less than the total capacity of the interiorchamber. That is, the subcritical water is released under the interiorfluid pressure of chamber 210 and when pressure inside the chamber isequalized with external pressure, then the flow will terminate. In use,the physician can optionally program a controller 295 to modulate theheating mechanism 250A after observation of signals from the temperaturesensor 294. In one variation, the controller 295 may be configuredactuate the release valve 222 in response to a signal from temperaturesensor 294 that a targeted temperature has been achieved, for example aselected temperature between about 105° C. and 300° C.

Now turning to FIGS. 5 and 6A-6B, another variation of device 400 isshown that comprises an elongated flexible catheter body 405 that has adistal end portion 408 that carries a needle portion 410 with outflowports or apertures 412 in a working end 415 thereof. An interior chamber420 communicates though flow channel 422 with the needle portion 410which is similar to the previous embodiment. Again, the capacity of theinterior chamber 420 can be small and can contain from less than onedrop to about 10 drops of subcritical water 122 when ready for use inablating tissue. In this variation, the release mechanism for releasingthe subcritical water from interior chamber 420 comprises a single-usevalve or fluid release mechanism 425 that has an actuatable shape memoryalloy (SMA) valve seat 428 described in more detail below, however, anysuitable type of valve known in the art that is capable of containingthe fluid pressures described above can be used.

As can be seen in FIGS. 5 and 7, the device has a flexible catheter body405 that can have any suitable length for reaching a targeted site apatient's body, typically by navigation through a body lumen or bodycavity. FIG. 7 illustrates an exemplary ablation of a targeted site 440,such as an ulcer, lesion or tumor in a stomach 442 with the device 400of FIG. 5. It should be appreciated that a catheter device 400 as inFIG. 5 can be navigated through any body lumen or passageway to treattissue, such as an esophagus, a stomach, an intestine, a nasalpassageway, a cervical canal, an airway or a passageway in a lung, aurethra, a ureter, bladder or the like. Typically, the catheter body 405as depicted in FIG. 7 is introduced through the working channel 444 ofan endoscope 445 or adjacent to an endoscopic viewing mechanism. In FIG.7, an articulating endoscope or gastroscope 445 has been introducedthrough the esophagus 448 into the patient's stomach 442. Thearticulating endoscope 445 is manipulated to view the targeted tissue440 and thereafter the catheter body 405 is introduced through theworking channel 444 of the endoscope 445 to interface with the targetedtissue 440. With the endoscope 445 in the correct position, thephysician then can advance the needle portion 410 of the device 400 intothe target 440. Thereafter, the valve mechanism is opened to release thesubcritical water to ablate the targeted tissue 440. As describedpreviously, the dimensions of the targeted tissue 440 can be evaluatedin advance and the physician can select a device 400 that has apreselected ablation capacity to match the ablation requirements.

Now turning back to FIG. 5, the sectional view of the distal end portion408 of the catheter body 405 illustrates the heating mechanism and valveor subcritical water release mechanism 425. In this variation, theflexible catheter body 405 can comprise any polymer extrusion that isknown in the art of fabricating catheters. The interior chamber 420 cancomprise the bore of a rigid stainless steel hypotube 460 with aproximal end cap 462 welded therein and a distal endcap 464 which isconnected to needle portion 410. The hypotube 460 is surrounded by aninsulator or dielectric layer 465, which can be a polymer or ceramic.Again, the fluid capacity of the of interior chamber 420 is limited, forexample, less than 20 drops or less than 10 drops. In other variationsdescribed below, the interior chamber 420 can be carried in anarticulating or bendable slotted metal hypotube with a flexible polymerliner (see FIG. 9).

As can be seen in FIG. 5, the heating mechanism in the device 400comprises an inductive heating coil 468 coupled to electrical source470. The inductive coil 468 extends helically around the hypotube 450and is adapted to inductively heat the hypotube 450 together with a heattransfer element 472 that can be inductively heated in the interiorchamber 420. Thus, in this variation, the subcritical water in interiorchamber 420 can be provided by heat transfer from either or both of thewall 474 of hypotube 460 around the interior chamber 420 and at leastone heat transfer element 472 in the interior chamber 420.

In the embodiment of FIG. 5, the heat transfer element 472 is also acomponent of the valve or subcritical water release mechanism. As shownin the sectional view of FIGS. 5 and 6A-6B, the distal end 475 of heattransfer element 472 is linear with a tapered valve end 477 that extendsinto the shape memory alloy (SMA) valve seat 428 that has passageway 482extending therethrough. FIGS. 6A-6B illustrate only the hypotube 450 andvalve mechanism of the variation of FIG. 5 without the heating mechanismor catheter body. The SMA valve seat 428 is fixed in distal endcap 464by welds 488. FIG. 6A shows the SMA valve seat 428 has a firstvalve-closed shape in which the SMA valve seat 428 has a temporaryextended length L so that tapered valve end 477 extends into seatsurface 489 of valve seat 480 to thereby close off the interior chamber420. FIG. 6B shows the SMA valve seat 428 can be transitioned to asecond valve-open or memory shape with length L′ in which the valve seat428 moves so that the valve seat surface 489 is away from the taperedvalve end 477 to thereby open the interior chamber 420 to allow a flowof subcritical water 122 through passageway 482 to the needle portion410. The SMA valve seat 428 is configured for transition from theelongated shape of FIG. 6A to the shortened shape of FIG. 6B by heattransfer from the subcritical water 122 while still contained in theinterior chamber 420. Thus, the heating mechanism has dual functions,that is, first to heat the contents of the interior chamber to providesubcritical water 122 which then in turn actuates the SMA valve seat 428to thus the valve to release the subcritical water as shown in FIGS. 6Band 8.

In a typical TiNi alloy, the transition temperature may be 30° C. to 40°C. but other shape memory alloys can have higher temperatures forthermal hysteresis and are useful for the valve mechanism describedabove, such as a ternary NiTiNb alloy that includes Niobium which canincrease the transition temperature to 120° C. or more.

The shape memory alloy valve mechanism in FIGS. 5 and 6A-6B shows avalve seat 428 that can be transitioned between a temporary shape and amemory shape to close and open a valve, but it should be appreciatesthat the element carrying tapered valve end 477 also (or alternatively)can comprise a shape memory material which can transition to a memoryshape to open the valve mechanism.

FIG. 8 schematically illustrates the flow of subcritical water 122 frominterior chamber through passageway 482 to outflow apertures 412 in theneedle portion 410 which interfaces with tissue 490. In general, amethod as shown schematically in FIGS. 7 and 8 comprises introducing theworking end of an energy delivery device of FIG. 5 into a targeted sitein an interior of a patient's body and providing a flow of subcriticalwater 122 from an interior chamber 420 through at least one aperture 412in the needle portion 410 to thereby interface with tissue and deliverablative energy to the targeted site 440.

FIG. 9 is a schematic view a distal portion of an alternative catheter500 that again has a catheter body 510 that carries an interior chamber520 adapted to carry subcritical water. The catheter body 510 againtransitions in the distal direction to a needle portion 522. In thisvariation, the working end 524 including the interior chamber 520 isflexible to allow the catheter body 510 to flex when in a workingchannel of an articulating endoscope. In this variation, the interiorchamber 520 can be within a flexible polymer sleeve 528, for examplefabricated of PEEK tubing or another similar material. The polymersleeve 528 is carried within the bore of a slotted metal hypotube orsleeve 530 as is known in the art for providing an articulating metalsleeve. In FIG. 9, the slotted sleeve 530 is shown in a form that allowsfor bending in one plane, but it should be appreciated that the sleevecan be slotted for flexing in any direction. As can be understood, theslotted metal sleeve 530 thus provides substantial strength surroundingthe PEEK tubing 528 so that the pressure in the interior chamber 520cannot expand the PEEK tubing radially outward from the axis 535 of thecatheter. In this schematic illustration of FIG. 9, the heatingmechanism is not shown, however, the heating mechanism can be aresistive heating element in interior chamber 520 of the type shown inFIG. 4A or an inductive heating system as shown in the embodiment ofFIG. 5 were in the inductive coil would add another layer to theexterior of the catheter body 510 as shown in FIG. 9.

In another variation, first and second concentric slotted tubes (notshown) can be used with distal ends of such tubes welded together and ahandle mechanism to axially move the first tube relative to the secondtube to provide an articulating catheter working end that carriesinterior chamber 520.

FIGS. 10A-10B illustrate another variation of a similar treatment device600 with a working end of a probe body 605 carrying an interior chamber620 and a distal needle portion 625. The interior chamber 620 can becarried within metal sleeve member 625 with a dielectric surroundinglayer 630. The interior chamber 620 again is adapted to carrysubcritical water and a valve or release mechanism 640 is adapted forreleasing subcritical water into a flow passageway 642 extending throughthe needle portion 625 to at least one aperture 628 therein. The heatingmechanism can be in the form as described previously where a helicalcoil 644 outward from dielectric layer 630 is coupled to electricalsource 645 and is configured to inductively heat a wall 646 around theinterior chamber 620 as well as heat transfer element 648 carried withinthe interior chamber. In this variation, the heat transfer element 648is a helical spring element.

The variation of FIGS. 10A-10B differs from previous embodiments in twoways. First, the interior chamber 620 includes a piston 650 that isurged in the distal direction by a spring 652 wherein the fluid contentsof the interior chamber when under pressure compress the piston 650 andspring 652. The piston 650 is illustrated with o-ring 654. As can beeasily understood, during use, as the valve mechanism 640 (describedbelow) can be opened to allow release of subcritical water, and then thepiston 650 and spring 652 will be urged the distal direction under theforce of spring 652 to eject a significant percentage of the totalvolume of subcritical water from interior chamber 620, which was not thecase in previous embodiments. Further, the heat transfer element 648carried within interior chamber 620 which is adapted for inductiveheating can be a collapsible spring-like member which is far weaker thanthe piston spring 652.

The variation shown in FIGS. 10A-10B differs from previous embodimentsin a second aspect, relating to the valve mechanism 640. In thisvariation, the valve mechanism 640 includes an actuatable valve shaft660 adapted to move a tapered valve stern 662 relative to a valve seat665 which moves transversely relative to the axis of the flow passageway642. As can be seen in FIG. 10A, the valve shaft 660 is slidablydisposed in a bore 668 in valve body 670. The outward end 672 of valveshaft 660 is coupled by weld 674 to the outward end of bore 668 in thevalve body 670.

The tapered valve stem 662 is fixed to the SMA valve shaft 660 whichagain can be any shape memory alloy such as NiTi described previously.The SMA valve shaft 660 has a first temporary extended length LL shownin FIG. 10A and a second shortened memory length LL′ shown FIG. 10B. Inother words, the tapered valve stem 662 is seated in valve seat 665 inFIG. 10A when the SMA valve shaft 660 is in its temporary shape toprovide a valve-closed position. Thereafter, heating the SMA valve shaft660 will cause it to shorten to its memory shape to move the valve stem662 away from valve seat 665 to provide a valve-open position which thusreleases subcritical water from the interior chamber 620. The heatingmechanism for heating the SMA valve shaft 660 can be a resistive heatingelement 680 coupled to electrical source 685 as shown in FIGS. 10A-10Bwhich is coupled by electrical leads in cable 686 indicatedschematically.

FIG. 11 illustrates another variation of a treatment probe 700 with aworking end body 705 extending about axis 708 that again carried aninterior chamber 710 and is connected to a distal needle portion 715.The probe of FIG. 11 differs from previous embodiments in that itadditionally provides a pulsing mechanism for pulsing the release ofsubcritical water from the interior chamber 710. In the probe of FIG.11, the interior chamber 710 has metal walls 718 surrounding a generallyannular chamber portion 720 wherein a central wall portion 722 has abore 724 with a motor-driven rotatable valve shaft 725 therein. Thedistal end 728 of the shaft 725 transitions to a rotating valve member730 which flow channel 732 a therein that when rotated will align withflow channel 732 b in valve seat 735 to provide respective valve-closedand valve-open positions. An enlarged, exploded view of the rotatingvalve member 730 and valve seat 735 is shown on the right side of FIG.11. The valve seat 735 has a distal end 736 that transitions to theinterior passageway 740 in the needle portion 715 as in previousembodiments.

FIG. 11 illustrates the proximal end 742 of valve shaft 725 beingcoupled to a typical motor drive 745 which can rotate that shaft atselected speeds to rapidly move between valve-open and valve-closedpositions to thereby pulse the flow of subcritical water 122 from theinterior chamber 710 through the valve seat 735. In the variation ofFIG. 11, an inductive coil 748 of the type described previously is shownconnected to an electrical source and controller 750. The pulse rate canvary from 1 pulse/sec to 500 pulses/sec. The valve shaft can 725 can bestopped with the rotating valve member 730 in the valve-closed positionby using a controller 750 and a motor drive 745 with an encoder or aspring mechanism can be used to stop rotation of the shaft 725 in aselected position.

The inductive coil 748 is adapted to heat the metal walls 718 and 722around the interior chamber 710 but it should be appreciated thatadditional inductively heatable elements (not shown) can be carriedwithin the interior chamber 710 as in previous embodiments. Further, apiston and spring arrangement having an annular configuration can beprovided in the variation of FIG. 11 which would serve the functionsdescribed with reference to the device of FIGS. 10A-10B.

FIG. 12 illustrates an ablation procedure with a probe 700 that has apulsing mechanism as shown in FIG. 11 in a method of treating ahemorrhoid 704. In FIG. 12, the needle portion 715 of the probe 700 isinserted into a patient's hemorrhoid 704 and subcritical water isreleased in pulses from interior chamber 720 as described above. In thetreatment of a hemorrhoid, the needle tip 724 can be moved axiallyduring the pulsed energy delivery. Further, in large hemorrhoids, theneedle portion 715 can be inserted at different locations or angled indifferent directions and thereafter the pulsed flows can be provided tooptimize ablation of all regions of the vascular malformation that makesup the hemorrhoid.

FIG. 13 illustrates the treatment of a keloid 740 or abnormal scartissue with a probe of the type shown in FIG. 11. A keloid can consistof fairly dense tissue, and therefore multiple sticks of the needleportion 715 may be optimal and the pulsed release of subcritical waterfrom interior chamber 710 can cause better energy penetration into thetissue which will be followed by resorption of ablated tissue to reduceand/or eliminate the keloid 740.

FIG. 14 schematically illustrates another catheter or probe 800 with aworking end 802 extending to a needle portion 805 that is similar to theembodiments described above. In this variation, the probe 800 carries aplurality of interior chambers 810A and 810B and cooperating valvemechanisms 812A and 812B to allow for sequential energy delivery fromeach interior chamber. In this variation, such interior chambers 810Aand 810B can be side-by-side or spaced axially apart within the workingend 802. The number interior chambers can range from 2 to 6 or more, andeach interior chamber can have an independent heating mechanism of anytype described previously or a single heating mechanism can be used toheat all the interior chambers simultaneously to provide subcriticalwater. In any event, each valve mechanism 812A and 812B can be openedindependently of any other valve mechanism. The use of multiple interiorchambers 810A and 810B provides for enhanced safety since the failure ofany valve can only release energy from a single small chamber ratherthan a single larger interior chamber. In this variation, the multiplechamber device then provides for an increased total of amount of energythat can be delivered from the probe. Each chamber 810A and 810B cancarry a predetermined energy dose which allows for less complex,single-use valves that are openable but not closeable as describedabove.

FIG. 15 illustrates a method of using the catheter 800 of FIG. 14 intreating a cancerous nodule 822 in a patient's lung 825. It should beappreciated that an elongated catheter 800 with multiple interiorchambers 810A and 810B (FIG. 14) is useful in a treatment which requirestime-consuming navigation of the catheter working end 802 to thetargeted site and thereafter may require multiple needle sticks. Theneed for multiple needle sticks may be needed in treating lung cancersites. In FIG. 15, it can be seen that the working end 802 is extendedoutwardly from endo scope 826 and the needle portion 805 is insertedinto the nodule or tumor 822 in multiple locations as is needed toablate the entire nodule or multiple nodules. Alternatively, oradditionally, the needle tip 828 can be penetrated into the wall 832around the lumen 836 to ablate blood vessels 840 therein that feed themalignancies.

FIGS. 16A and 16B illustrate another probe 850 with a probe body 852 andworking end 855 that is similar to that of FIGS. 2, 4A, 5, 9, 10A and 11but which differs in that the working end includes an extendable needleportion 860 that can be extended at a highly accelerated rate from theprobe body 852 for penetrating tissue. More particularly, the needleportion 860 can be extended ballistically by the fluid pressure andexpelling forces provided by the release of pressurized thermal fluid orsubcritical water 122 from the interior chamber 870 shown schematically.In other words, the needle portion 860 can be driven into tissue at ahigh speed as opposed to inserting the needle portion under manualforce. The use of pressure driven needle insertion is useful when theneedle is at the end of an elongate probe, for example, as shown in FIG.11 or other treatments were an endoscope is navigated through a bodylumen and the needle portion 860 is carried by elongated catheter ordevice 850.

Referring to FIG. 16A, it can be seen that the needle portion 860 is ina retracted or non-extended position within a cylindrical channel 872 inthe working end 855 of the probe body 852. The release mechanism 875 isshown in flow passageway 876 that leads to channel 872 carrying theextendable needle portion 860. The needle portion 860 has a proximalcollar 880 with an o-ring 882 that seals the collar 880 in thecylindrical channel 872. It can be understood that in an extendedposition, the collar 880 bumps into the distal flange 884 around thechannel 872 to thereby limit the distal travel of the needle portion860.

Now referring to FIG. 16B, the needle portion 860 can be seen in anextended position relative to the probe body 852. It can easily beunderstood that when the release mechanism 875 releases subcriticalwater from the interior chamber 870, the high fluid pressure will causethe needle portion 860 to accelerate towards the extended position ofFIG. 16B at the same time that fluid flow through the interiorpassageway 886 of the needle portion to the outflow apertures 888. Itcan be understood that the fluid pressure will cause the needle portion860 to accelerate in any design in which the flow passageway 886 in theneedle portion 860 restricts the flow of the thermal fluid through thepassageway 886 and outflow apertures 888.

FIGS. 17A-17B illustrate another variation of a valve mechanism orsubcritical water release mechanism 900 which is space-saving and issuitable for use in the working end of an elongate catheter as in FIG.14 since no electrical connections are needed to actuate the mechanism.FIG. 17A illustrates a probe body 905 with an interior chamber 910 shownschematically that carries subcritical water 122 as describedpreviously. The probe body 905 extends distally to a needle portion 915.For convenience, a heating mechanism is not shown in FIGS. 17A-17B, butcan be any of the heating mechanisms described in previous embodimentsabove. The valve mechanism 900 consists of a magnetically-controlledpressure relief valve disposed in a cylindrical chamber 918 between theinterior chamber 910 and flow passageway 920 in the needle portion 915.As can be seen in FIG. 17A, a first permanent magnet 922A cooperateswith a second permanent magnet 922B to provide a valve-closed position.The magnets can be a rare-earth type such as neodymium magnets. In FIG.17A, the first or proximal magnet 922A is fixed mechanically, or byadhesives, in the proximal end 924 of cylindrical chamber 918. A flowchannel 928 extends through the first magnet 922A and an optionalpolymer washer 932 attached to the distal surface 936 of the magnet922A.

In FIG. 17A, the second or distal magnet 922B is dimensioned to float ormove within the cylindrical chamber 918. A polymer washer 940 isattached to the proximal surface 942 of magnet 922B and a seal or o-ring945 is coupled to the washer 940. At least one flow channel 950 isformed into an outer perimeter of the distal magnet 932B and washer 940,and the variation of FIG. 17A illustrates four perimeter flow channels950. Thus, in FIG. 17A, it can be seen that the magnetic attractionbetween magnets 922A and 922B will provide a valve-closed position andseal the interior chamber 910.

FIG. 17B next depicts an increase in fluid pressure in interior chamber910 which overcomes the magnetic attraction between magnets 922A and922B and thereafter the distal magnet 922B is displaced in the distaldirection in cylindrical chamber 918 to provide a valve-open position.The magnetic valve 900 can perform optimally in this application sinceits release or opening is very fast and can be designed to fully open ata precise cracking pressure to provide a fully-open position and afully-closed position. The fully-open position of FIG. 17B is achievedpractically instantly due to the rapid decay of the magnetic field asthe fluid flow pushes the second magnet 922 to the open position. Thismagnetic mechanism differs from spring-based pressure relief valves thatrequire increasing pressure and force to continually compress the springand open a conventional pressure relief valve.

In FIG. 18 illustrates another magnetic release mechanism 960 which issimilar to that of FIGS. 17A-17B except that the distal magnet 965 is aspherical magnet that is configured to float or move within thecylindrical chamber 918 between a valve-closed position CP and an openposition OP. In this variation, the proximal magnet 922A′ can have apolymer or elastomeric sealing washer 970 attached to the distal surfaceof the magnet to provide a seal against the spherical magnet 965. In anyof the variations of FIGS. 17A and 18, the walls of the cylindricalchamber 918 can have an insulative layer (not shown), such as a ceramic,to limit heat transfer to the device body 905. Similarly, the magnets922A, 922B or 922A′ and 965 can have a. surface layer of a ceramic orother thermal insulator.

FIGS. 19A-19B illustrate another system 1000 corresponding to theinvention for performing an ablation procedure, that comprises multiplecomponents, including an endoscopic viewing component or endoscope 1005,an articulating sleeve assembly 1010 and an ablation stick or probe 1020that is similar to the variations described above. In one variation, thesystem 1000 has an elongate endoscope 1005 that is less or equal to 6 mmin diameter DD and is often less than 5 mm diameter that carries adistal imaging sensor 1022 having field of view FOV for endoscopicviewing as is known in the art. The imaging sensor 1022 can be angledhave any suitable viewing angle from 0° to 70° or more for particularprocedures and different angles of field of view. Additionally, theendoscope 1005 may carry one or more channels 1024 a and 1024 b forfluid inflows and outflows or for pressure sensing. The endoscope 1005also would carry LEDs or another light transmitting mechanism (notshown). The endoscope 1005 may be disposable and has a working channel1025 that has a diameter ranging between 2 mm and 4 mm. Thus, the system1000 allows for navigation within a lumen in the patient's body with anendoscope 1005 that is less than 6 mm in diameter and an ablation probe1020 with a working end 1040 that can be advanced and rotated relativeto an articulating sleeve 1010 to thereby direct a needle portion 1044(FIG. 19B) in any direction desired to deliver ablative energy totissue.

As can be understood from in FIG. 19A, the articulating sleeve 1010 canconsist of concentric first and second slotted hypotubes indicated at1048 (collectively) that can be articulated from a proximal handle (notshown) as is known in the art. The articulating region 1052 of thesleeve assembly 1010 can articulate up to 90° or more from itslongitudinal axis 1055. Further, the articulating region 1052 can berotated 360° within the working channel 1025 as well as translatedlongitudinally relative to endoscope 1005 and the imaging sensor 1022.As can be seen in FIG. 17A, the central channel 1060 in the articulatingsleeve assembly 1010 is adapted to receive the elongate, flexibleablation stick or probe 1020 of the type described in FIGS. 16A-16Babove. Thus, FIG. 19A depicts initial steps of a method of using thesystem 1000 wherein (i) the endoscope 1005 is navigated into theinterior of a patient's body proximate to targeted tissue TT, (ii) thearticulating sleeve assembly 1010 is introduced through the workingchannel 1025 in the endoscope 1005 and the articulating region 1052 isarticulated, and (iii) the ablation probe 1020 is inserted through thecentral channel 1060 of the sleeve assembly 1010 so that its working end1040 (with its needle portion 1044 retracted) is in contact with thetargeted tissue TT.

FIG. 19B illustrates a subsequent step in a method of ablating thetargeted tissue TT wherein a release mechanism, such as the subcriticalwater release mechanism of FIGS. 17A-17B is used in conjunction with aheating mechanism to cause (i) ballistic extension of the needle portion1044 into the targeted tissue TT and (ii) flow of the thermal treatmentfluid through apertures 1064 in the needle portion 1044 to interfacewith tissue to cause the ablation. In this variation, the ablation probe1020 again provides a source of thermal treatment fluid in a specifiedvolume or having a specified energy delivery capacity. In general, thesystem 1000 of the invention includes an elongated member or endoscope1005 carrying a distal imaging sensor, and articulated sleeve assembly1010 that carries a central channel 1060, and a flexible ablation probe1020 adapted for providing a thermal ablation fluid to interface withtissue wherein the system 1000 is configured to deliver one or moredoses of energy where each dose ranges from 5 to 1000 calories. Althoughthe system 1000 is described with separable components, variationsinclude an endoscope 1005 and the articulating sleeve 1010 that arecombined into a single disposable component, or an articulating sleeve1010 and ablation probe that are combined into a single disposable orall three components can be combined and fall within the scope of theinvention.

FIGS. 20A-20C illustrate in ablation system that can be assembled fromindividual functional components that are separately packaged in steriletrays to provide a custom treatment kit. FIG. 20A illustrates anelongated flexible endoscope component 1100 of the type that can be usedfor accessing a patient's lung or a treatment site in a patient'sgastrointestinal tract, which may be an articulating endoscope as isknown in the art. The endoscope 1100 is shown in tray 1005 with the traytop 1106 removed. In one variation, the endoscope 1100 has a distalimaging sensor 1112 is a working channel 1115 extending from the handle1116 through the endoscope. Light fibers and additional fluid flowchannels can be provided in the endoscope as is known in the prior art.A multifunctional cable 1118 extends from the endoscope 1000 to a lightsource, an imaging processor and an image display system as is known inthe art.

FIG. 20B then illustrates an elongated articulating catheter 1120 with adistal articulating region 1122 that is dimensioned for introductionthrough the working channel 1115 in the endoscope 1100 of FIG. 20A. Thecatheter 1120 has an interior passageway 1124 and is shown in steriletray 1125 with the tray top 1126 removed. The handle 1128 of thecatheter includes an actuator, for example a rotating member 1130, thatis configured to articulate the articulating region 1122 of the catheterthat extends outwardly from distal end of endoscope 1100 of FIG. 20Awithin the endoscope's field of view.

Finally, FIG. 20C illustrates an elongated ablation probe 1140 with anextendable needle 1144 shown in an extended position for purposes ofdescription only. The needle assembly is similar to needle typesdescribed previously. The ablation probe 1140 in tray 1145 comprises ahighly elongated flexible shaft 1146 that can be introduced through thepassageway 1124 in the articulating catheter 1120 of FIG. 20B to extendoutwardly from the distal end of the catheter 1120. The physician thencan rotate and articulate the articulating catheter 1120 which will flexthe distal end 1154 of the ablation probe 1140 and orient the needle1144 at any rotational angle and direction for penetrating the needle1144 into a targeted site. It can be understood that the ablation probe1140 can be selected from inventory of probes, based on probe operatingparameters and configurations, for example including (i) total energydelivered by subcritical water release, (ii) selected rate of energydelivery over a selected time interval, (iii) needle length for depth ofpenetration; (iv) needle gauge, (v) needle rigidity or flexibility, (vi)dimensions and orientation of flow outlets in the needle, (vii)acceleration rate of the needle for penetrating tissue, (viii)retractability or non-retractability of the needle, (ix) type of releasemechanism for releasing subcritical water from an interior chamber forflow to the needle, and (x) selection of a probe with a single chamberor multiple chambers for delivering subcritical water to a targetedsite.

FIGS. 21A-21C illustrate another variation of ablation system or kitthat is similar to FIGS. 20A-20C except that FIG. 21A-21C illustrate anendoscope 1150 and other components that are relatively short ratherthan the elongated flexible endoscope 1100 and kit of FIGS. 20A-20C. Inthis variation, FIG. 21A illustrates a rigid endoscope 1150 that be usedin gynecology, ENT, urology, laparoscopy or the like. The endoscope 1150is shown in tray 1155 with the tray top 1156 removed. In a variation,the endoscope 1150 has a distal imaging sensor 1162 and a workingchannel 1165 extending from the handle 1166 through the endoscope.

FIG. 21B depicts a cooperating articulating catheter 1170 that hassuitable length for extending through the working channel 1165 of theendoscope 1150. The catheter handle 1172 has an actuator element 1174for articulating the articulating region 1175 of the catheter asdescribed previously.

FIG. 21C shows an ablation probe 1180 has a flexible distal section 1182that is adapted to cooperate with the articulating region 1175 of thecatheter 1170 of FIG. 21B. Again, the ablation probe 1180 can beselected from an inventory of probes to provide the selected ablationparameters and a needle configuration as described previously withreference to FIG. 20C.

FIG. 22A is a sectional view of a working end 1200 of another variationof ablation probe 1204 with a distal needle 1205 in a non-extendedposition. In this variation, the probe body 1210 carries a movableneedle assembly 1215 that carries the fluid-filled chamber 1220, whereinthe needle assembly 1215 comprises a movable component that can beadvanced outwardly from the probe body 1210. The needle assembly 1215further carries a release mechanism 1222 of any type describedpreviously. As can be seen in FIG. 22A, the needle assembly 1215 ismovable within a cylindrical bore 1224 of the probe body 1210. Forclarity in describing the needle advancement mechanism in thisvariation, FIGS. 22A-22B do not illustrate the heating mechanism that isused to provide the subcritical water in fluid-filled chamber 1220.However, it should be appreciated that any of the heating mechanismsdescribed in previous embodiments can be integrated into the variationof FIGS. 22A-22B.

In the probe of FIGS. 22A-22B, the needle assembly 1215 is configuredfor ballistic advancement from the non-extended position of FIG. 22A tothe extended position of FIG. 22B. As can be seen in FIG. 22A, a fluidvaporization chamber 1225 is provided in the body 1210 proximal to theneedle assembly 1215 and an electrode arrangement comprising opposingpolarity electrodes 1240A and 1240B is provided to delivery energy tothe fluid vaporization chamber 1225. As can be seen in FIG. 22A, theneedle assembly 1215 includes an O-ring 1228 is a fluid seal incylindrical bore 1224. The electrodes 1240A and 1240B are operativelycoupled to an energy source 1250 and a controller 1255 for the deliveryof energy to fluid 1252 in chamber 1225. The fluid 1252 can be sterilewater in the energy delivery from the energy source 1250 will besufficient to explosively vaporize the fluid 1252 to thereby instantlyaccelerate the needle assembly 1215 distally in the probe body. It canbe understood that the phase transition of the fluid 1252 from a liquidto a gas can increase the fluid volume by 1000× or more to thereby movethe needle assembly 1215 to the extended position of FIG. 22B. The probebody 1210 further can have a pressure relief valve (not shown)communicating with the vaporization chamber 1225 to preventoverpressures therein. FIG. 22B illustrates the needle 1205 of FIG. 22Ain an extended position following the explosive vaporization of fluid1252 in the vaporization chamber 1225 to move the needle from thenon-extended position to the extended position.

Still referring to FIGS. 22A-22B, the controller 1255 is configured toallow the operator to select among a plurality of lower and higherenergy levels that can be delivered from the energy source 1250 to thefluid 1252 in the vaporization chamber 1225 wherein each energy levelwill cause a different amount of vapor expansion which in turn providesfor a selected, different acceleration rate of the needle 1205 intotissue. Such differing acceleration rates are useful depending on theselection of needle length and needle gauge as well as thecharacteristics of the targeted tissue, such as tissue density anddifferent tissue layers that may need to be penetrated.

In general, a method of needle injection responding to the inventioncomprises providing an injector body that carries a distal needle thatis movable between a non-extended position and an extended positionrelative to the injector body, wherein a fluid-filled chamber isprovided in the injector body proximate to said needle, and causingexplosive vaporization of a fluid in said fluid-filled chamber tothereby move the needle from the non-extended position to the extendedposition. While the embodiment of FIGS. 22A-22B show an electricalsource coupled to an electrode arrangement to cause the vaporization ofthe fluid 1152 in a chamber, it should be appreciated that any energysource may be used for example an RF source, a laser source, a microwavesource, an ultrasound source or a resistive heating mechanism.

FIG. 23A is a view of the working end 1300 of another ablation probewhich is similar to that of FIG. 22A with a distal needle 1305 in anon-extended position. In this variation, a spring mechanism is adaptedfor advancing the needle 1305 to the extended position from thenon-extended position together with an adjustment mechanism that canadjust the spring mechanism to provide a plurality of needleacceleration rates.

In the variation of FIGS. 23A-23B, the probe body 1310 again carries amovable needle assembly 1315 that carries an interior chamber 1320 forcontaining the subcritical water. The needle assembly 1315 is movable ina cylindrical bore 1318 in the probe body 1310. For clarity indescribing the needle advancement mechanism, FIGS. 23A-23B do notillustrate the heating mechanism for providing the subcritical water infilled chamber 1320, which can be any of the previously describedheating mechanisms.

FIGS. 23A-23B further show that the housing component 1335 of the needleassembly 1315 that surrounds the interior chamber 1320 is coupled to anelongated shaft 1340 that extends proximally to a handle portion (notshown) of the probe body 1310. The elongated shaft 1340 can be flexibleor rigid depending on the configuration of the probe body 1310. As canbe seen in FIG. 23A, a helical spring 1344 is disposed around the shaft1340 in a compressed condition and is adapted to urge the needleassembly 1315 in the distal direction when tension on the helical spring1344 is released. It can be understood that the shaft 1340 in a proximalportion of the probe 1310 has can have a locking-release mechanismindicated schematically at 1348 for locking the shaft 1340 in a cockedposition as shown in FIG. 23A. Any type of lock-release mechanism 1348can be used to retain and release the shaft 1340. FIG. 23B shows theneedle assembly 1315 and shaft 1340 after the lock-release mechanism1348 has released the shaft 1340 to thereby allow the helical spring1344 to urge the needle assembly 1315 to the needle-extended position.In this variation, it can be understood that the needle assembly 1315could be returned to, and locked in, the cocked position of FIG. 23A forone or more additional uses. In such a variation, the needle assembly1315 that have multiple interior chambers in release mechanism as shownin the variation of FIG. 14. In contrast, the previous embodiment ofFIGS. 22A-22B which is a ballistic needle advancement mechanism isadapted for a single use.

In another aspect, still referring to FIGS. 23A-23B, the probe body 1310includes a spring adjustment mechanism which can comprise a threadedbody 1350 or any other movable body that can alter the spring tensionwhen the needle assembly 1315 and spring 1344 are moved to thenon-extended, or cocked, position of FIG. 23A. It can be understood thatthe threaded body 1350 can move longitudinally within the probe body1310 to change the compressed length of the helical spring 1344 whichthereby in turn can allow for adjustment of the acceleration rate of theneedle assembly 1315 when the lock-release mechanism 1348 releases theneedle assembly 1315 to penetrate the needle 1305 into tissue. FIG. 23Billustrates the needle 1305 in an extended position following therelease of the lock-release mechanism 1348 that allows the spring 1344to move the needle from the non-extended position to the extendedposition.

FIGS. 24-26B illustrate another system 1400 that is similar to previoussystems in some aspects in that an ablation device or stick 1405 isprovided with a first energy source 1410 for providing a subcriticalcritical liquid 1412 in an interior chamber 1415 of the shaft portion1416 of the ablation stick 1405 that communicates with a flow outlet1420 in a needle portion 1422 of the device. However, the system 1400 ofFIG. 24 differs from previous embodiments in that the ablation stick1405 is adapted to deliver greater ablative energy to tissue by ejectingsuch a subcritical liquid media from the flow outlet 1420 of the needle1422 and contemporaneously coupling electrical energy from a secondenergy source 1425 to the media flow to thereby ionize such a media flowwherein the ionized media flow then can deliver enhanced ablative energyto tissue in a targeted site.

Still referring to FIG. 24, the system 1400 furthers include anendoscope 1430 that can be similar to any endoscopes illustrated inprevious embodiments. In FIG. 24, the endoscope 1430 is shown in a rigidversion with a handle portion 1432 and elongated shaft 1434 that carriesa distal imaging sensor 1435. In another variation (not shown), theendoscope can be configured with an articulating distal portion asdescribed above. The endoscope 1430 has a working channel 1440 forreceiving the ablation stick 1405 similar to previously describedembodiments. A video display or monitor 1442 of any type can be coupledto the endoscope 1430. The endoscope 1430 also can carry LEDs asdescribed previously as well as one or more flow channels for providingirrigation to and from a treatment site as is known in the art.

In the variation shown in FIG. 24, the ablation stick 1405 consists of abasic, simple configuration wherein the physician would introduce orstab the needle portion 1422 into a targeted tissue site underendoscopic vision as might be done in a treatment of submucosal fibroidsor similar targeted tissue in a body lumen or body cavity. In othervariations described below, the distal portion of the ablation stick1405 may include a spring mechanism for causing the needle portion 1422to penetrate targeted tissue.

In one variation, the distal end 1444 of the working channel 1440 caninclude features that cooperate with the distal end 1446 of the shaftportion 1416 of the ablation stick 1405 for maintaining or locking theshaft portion 1416 of the ablation stick in relation to the distal endof the endoscope 1430. Such a feature can comprise a simple stop collarto prevent the shaft 1416 of the ablation stick 1405 from extendingoutwardly from the endoscope 1430 while permitting the needle portion1420 to be advanced. In another variation, the threaded mechanism may beused to lock the distal end 1446 of the shaft portion 1416 into thedistal end 1444 of the working channel 1440.

Now referring to FIGS. 24 and 25A, it can be seen that ablation deviceor stick 1405 again includes an elongate needle portion 1422 which canhave any suitable length ranging from about 2 mm to 50 mm forpenetrating targeted tissue. In the variation shown in FIG. 25A, theelongated needle portion 1422 can be a rigid needle member or a flexibleneedle member of a polymer such as PEEK which extends distally from theshaft portion 1416 of the ablation stick 1405. A flexible needle portion1422 shown in FIG. 25A can thus be adapted to be advanced through acurved channel in an endoscope or other introducer member to advance theneedle portion 1422 at an angle relative to the axis AX of such anendoscope 1430 or introducer (FIG. 24) as will be described in laterembodiments.

Referring to FIGS. 25A and 25B, the needle portion 1422 has a singleflow outlet 1420 that is provided in the distalmost tip of the needleportion 1422. However, it should be appreciated that other variationscan be provided with a plurality of ports disposed around the distal endof the needle portion 1422 as described previously.

As can be seen in FIGS. 24, 25A and 25B, the shaft portion 1416 of theablation stick 1405 includes an interior chamber 1415 that is configuredto contain the subcritical liquid 1412 until the valve 1445 of anysuitable type is opened as described previously. The first electricalsource 1410 is configured to deliver energy through electrical leads1446 a and 1446 b to the interior chamber 1415 to provide thesubcritical liquid as described previously.

Still referring to FIGS. 24-25B, the second energy source 1425 isconfigured to deliver electrical energy to the subcritical media flowexiting the flow outlet 1420 of channel 1450 in the needle portion 1422.More in particular, FIGS. 25B, 26A and 26B shows the second independentelectrical source 1425 and electrical leads 1448 a and 1448 b thatextend through the shaft portion 1416 of the ablation stick 1405 tofirst and second electrodes 1460A and 1460B carried by the distal region1462 of the needle portion 1422 (FIGS. 26A-26B). In the elevational viewof FIG. 26A, it can be seen that the first electrode 1460A comprises aconductive plating carried on the exterior of a dielectric needleportion 1422. This electrode 1460A can comprise an electroless platingor a thin-wall conductive sleeve. The sectional view of FIG. 26B showsthat the second electrode 1460B is disposed around the surface of theinterior flow channel 1450 of the needle portion 1420 and consists of asimilar conductive plating or thin-wall sleeve. The electrical leads1448 a and 1448 b that extend to the first and second electrodes 1460Aand 1460B can also comprise conductive plating elements as are known inthe art. Thus, it can be seen how the spaced apart first and secondpolarity electrodes 1460A and 1460B can deliver electrical energy toflow media that exits the distal flow outlet 1420 of the flow channel1450 in the needle portion 1422.

FIG. 27 next illustrates a cut-away view of the distal portion theneedle portion 1420 similar to that of FIG. 26B embedded in the targetedtissue site 1470 with a flow of subcritical liquid media 1412 throughthe interior flow channel 1450 in the needle portion 1422 until suchmedia exits the flow outlet 1420 and electrical energy is delivered tosaid media flow by the spaced apart electrodes 1460A and 1460B tothereby ionize such a media flow. The arrows AR then illustrate theionized media flow outward into the targeted tissue 1470 which generallymay propagate in extracellular spaces 1472 which are shown schematicallybetween cellular structures 1475 (not-to-scale). By this means, the heatfrom the ionized media flow as well as the energy delivered by activelymoving ions of the ionized flow can enhance the ablative energy appliedto the targeted tissue 1470.

In the operation of the ablation stick 1405 of FIGS. 24-26B, it can beunderstood that the physician initially positions the needle portion1422 in the targeted site, and prior to or subsequent to suchpositioning of the needle portion activates the first electrical source1410 with a switching mechanism indicated at 1480 which is typicallycoupled to a controller 1485. Such a switch mechanism 1480 can bedisposed on the ablation stick 1405 or in the electrical conduitcoupling the electrical source 1410 to the ablation stick. Further, inone variation, one or more temperature sensors 1488 a and 1488 b (FIG.25B) are positioned about the interior chamber 1415 to monitor andcontrol fluid temperatures within the interior chamber 1415. Suchtemperature sensors 1488 a and 1488 b are configured to send signals tothe controller 1485 which then can modulate energy delivery from thefirst electrical source 1410 to maintain over time a targetedtemperature in the interior chamber 1415 to thereby provide thesubcritical liquid at the desired temperature and pressure as describedpreviously. Further, the controller 1485 may be adapted to control andmaintain the temperature at a two or more preselected temperatures tothus provide different amounts of delivered energy.

As can be understood from FIGS. 24-26B, a second switch mechanism 1490is coupled to the controller 1485 and ablation stick 1405 which isadapted to activate the second electrical source 1425 deliver electricalenergy to electrodes 1460A and 1460B to ionize the media flow fromoutlet 1420 in the needle portion 1422. In one variation, the valve 1445and the second switch mechanism 1490 are controlled by the controller1485 to energize the electrodes 1460A and 1460B contemporaneously withthe opening of the valve 1445, or energizing the electrodes 1460A and1460B slightly before the opening of the valve 1445. The valve 1445 canbe any of the types described previously or can be a specializedpressure relief valve.

FIGS. 28A-30B illustrate another embodiment of an ablation system 1500with an ablation stick or device 1505 with an interior chamber 1515configured to provide subcritical liquid and electrodes as in the deviceof FIGS. 24-26B for ionizing a media flow from the stick. The ablationstick 1505 thus is similar to that of the ablation stick 1405 of FIGS.24-26B, except that the device 1505 of FIGS. 28A and 28B includes aspring mechanism for advancing the needle portion 1520 an extensiondistance DD into a targeted tissue site. As can be seen in FIG. 28A, theablation stick 1505 has a shaft 1522 including a proximal shaft portion1524 and a spring-loaded distal shaft portion 1525 wherein the proximalshaft portion 1524 can be maintained in a fixed position relative toendoscope 1530 (FIG. 30A) or an introducer. The spring-loaded distalshaft portion 1525 then can be actuated to project distally andoutwardly from a working channel 1532 in the endoscope 1530 (see FIG.30A). As can be seen in FIG. 28A, the spring-loaded distal shaft portion1525 carries the interior chamber 1515 for providing subcritical liquid,the valve 1535 and needle portion 1520.

A first electrical source 1410, a second electrical source 1425 andcontroller 1485 are shown in FIGS. 28A-28B and 30A-30B which are adaptedto function the same manner as described previously. More in particular,referring to FIG. 28A, it can be seen that the ablation stick 1505 againhas first electrical source 1410 operatively coupled to interior chamber1515 for providing subcritical liquid 1412. The ablation stick 1515shown in FIGS. 28A-28B and 30A-30B further has second electrical source1425 which is adapted to energize an electrode arrangement 1540 in thedistal tip of needle member 1520 for ionizing the media flow asdescribed previously.

In FIGS. 28A and 30A it can be seen that the ablation stick 1505 furtherincludes an engagement mechanism or latch connector 1545 for connectingthe proximal shaft portion 1524 of the ablation stick 1505 to handle1548 of the endoscope 1530. Such a connector is shown as a flexiblesnap-fit mechanism that has tab elements 1552 that snap into groove 1554in the endoscope handle 1548. The tab elements 1555 can be flexed toremove the ablation stick 1505 from the endoscope handle 1548.

In FIGS. 28A and 29A, it can be seen that distal shaft portion 1525which carries the interior chamber 1515 is coupled to an elongateextension member 1560 that extends through bore 1562 in the proximalshaft portion 1524. In FIG. 28A, the spring 1565 is compressed as theextension member 1560 is moved proximally and a lock-release mechanism1570 coupled to the proximal end 1572 of proximal shaft portion 1524 isused to lock the extension member 1560 in a cocked position. Thelock-release mechanism 1570 can comprise a moveable locking element 1575that can be finger-actuated to move transversely in a first directionrelative to axis 1577 of the extension member 1560 to thereby grip andengage the extension member 1560 as illustrated in FIG. 28A. FIGS. 28Band 30B illustrate the locking element 1575 after being actuatedtransversely in a second direction relative to axis 1577 to therebyrelease its grip on extension member 1560 and thereby cause the needleportion 1520 to spring outwardly or the distal direction to therebypenetrate tissue. As can be seen in FIGS. 28B, 29B and 30B, the spring1565 is released from its compressed position of FIGS. 28A, 28B and 29Bat moves to a repose extended position that the projects the needleportion 1520 distally. FIG. 29A shows that a thin outer sleeve 1578 canbe provided to cover the spring 1565 while still allowing movement ofthe distal shaft portion 1525.

FIGS. 30A and 30B show the assembly of the ablation stick 1505 of FIGS.28A-28B with the endoscope 1530 showing a mode of operation of thesystem. In FIG. 30A, it can be seen that the latch connector 1545 hascoupled the ablation stick 1505 to handle 1548 of endoscope 1530 tothereby provide a fixed relationship between the ablation stick 1505 andthe endoscope. It should be appreciated again that the endoscope can bea rigid endoscope or an elongated flexible or articulating endoscope.FIG. 30B shows the release of the lock-release mechanism 1570 whichallows the needle portion 1520 to be advanced outwardly from the distalend 1582 of the endoscope 1530 to penetrate tissue an extension distanceof DD.

Now turning to FIGS. 31A-31C and 32, another variation of ablation stick1605 and specialized introducer and endoscope 1610 is shown that isadapted to penetrate the needle member into tissue at an angle relativeto the axis 1608 of the endoscope shaft 1612. FIG. 31A illustrates theablation stick 1605 separate from the endoscope 1610 wherein theablation stick is similar to the embodiments described previously, withfirst and second energy sources 1410 and 1425 for providing asubcritical liquid in an interior chamber 1615 for ejecting from aneedle member 1625. The ablation stick 1605 has a proximal portion 1616that includes a latch mechanism 1618 for latching onto the handle 1620of the endoscope 1610. The ablation stick in this variation has anelongated flexible needle member 1625 that is spring-loaded by spring1628 of the type described previously. A lock release mechanism 1630 isprovided to release the distal portion 1632 of the shaft 1635 of theablation stick 1605 allowing the needle member 1625 to penetrate tissue.Typically, the endoscope 1610 is adapted for single use and carries animaging sensor 1640 in its distal end as described in previousembodiments (see FIG. 32). The endoscope 1610 has a handle or grip 1644that can be a pistol grip or an in-line grip that is coupled to theendoscope shaft 1612. The endoscope shaft again carries a distal LEDs1648 and a channel 1650 which accommodates the ablation stick 1605 andneedle member 1625. As can be seen best in FIG. 32, the distal end ofthe endoscope shaft 1612 includes an extension member 1654 that extendsdistally a distance AA beyond the imaging sensor 1640. The extensiondistance AA may range from about 5 mm to 20 mm and more often is betweenabout 8 mm and 15 mm. In FIG. 32, it can be seen that the channel 1650has a distal portion comprising a curved needle channel 1658 that isadapted to receive and direct the flexible needle 1625 to extendoutwardly at a selected angle that can range from 30° to 90° relative tothe axis 1660 of the endoscope shaft 1612. Thus, as can been understoodfrom FIGS. 31C and 32, the positioning and extension of the needle 1625into tissue is within the field of view of the imaging sensor 1640.

Referring to FIGS. 31B, 31C and 32, the endoscope shaft 1612 also isadapted to provide fluid flows to a treatment site with a fluid inflowchannel 1665 extending to port 1668 and a fluid outflow channel 1670extending proximally from outflow port 1672. As can be seen in FIG. 31B,a fluid source 1680 is adapted to provide fluid inflows and can comprisea saline bag or other suitable fluid source. Such a fluid inflow can beprovided by gravity flow or by a pump system as is known in the art.Similarly, the fluid outflows can optionally be assisted by a pump andcollected in reservoir 1685.

FIG. 31B shows the ablation stick 1605 inserted into the endoscope 1610with the latch mechanism 1618 engaging the endoscope. In FIG. 31B, theablation stick 1605 is in the needle-cocked position wherein the spring1628 is compressed and ready for release to inject the needle member1625 into tissue. FIG. 31B schematically shows the endoscope shaft 1612introduced in a treatment site 1686 body lumen 1688 in phantom view.FIG. 31C shows the lock-release mechanism 1630 being actuated to releasethe needle member 1625 to penetrate targeted tissue 1690. As can be seenin FIG. 31C, the elongated flexible needle 1625 is advanced outward fromthe distal curve channel 1658 of the endoscope 1610 and extension member1654.

Of particular interest, referring to FIGS. 31B, 31C and 32, theendoscope shaft 1612 has an insertion profile that is less than 7 mm indiameter and often less than 6 mm in diameter and any suitable lengthfor introduction into a body lumen. In some cases, the diameter can beless than 5 mm in diameter which is made possible by the small size ofthe digital imaging sensor 1640. In such variations, the imaging sensor1640, the LEDs 1648, the inflow and outflow channels 1665 and 1670 allcan be accommodated together with the needle channel 1658 in the smalldiameter endoscope shaft 1612.

Thus, a method corresponding to the invention is shown in FIG. 33 andcomprises (i) introducing an endoscope shaft with a distal imagingsensor through a body lumen to a site, wherein the insertion profile ofthe endoscope shaft is less than 7 mm in cross section and the endoscopeshaft has a channel therein with a curved distal section for directing aflexible needle advanced therethrough; (ii) inserting a injector intothe channel, the injector having an interior chamber communicating witha flow outlet in a needle member, the interior chamber containing apre-selected volume of conductive liquid; (iii) observing the site withthe imaging sensor and actuating the injector to advance the needlemember through the curved channel and the lumen wall into targetedtissue; and (iv) ejecting subcritical liquid from the interior chamberto provide a subcritical liquid flow through the flow outlet andcoupling electrical energy to said flow to ionize the flow wherein theionized flow delivers ablative energy to the targeted tissue.

As described above, an energy source for providing the subcriticalliquid in an interior chamber of an ablation stick of the types shown inFIGS. 1B, 2, 4A, 5, 10A, 11, 14, 16A, 22A and 23A can be a source ofstored energy such as a battery, capacitor or supercapacitor.

FIG. 34 illustrates an ablation stick 100′ with interior chamber 120′that is similar to the embodiment of FIG. 2 except that the shaftportion 102′ of the ablation stick of FIG. 34 carries a storedelectrical energy component 1715 which can comprise at least onebattery, capacitor, supercapacitor or the like. It has been found thatthe power requirements for providing subcritical liquid 122′ in a smallvolume in interior chamber 120′ is quite small and can be provided by asuch a battery, capacitor or supercapacitor.

FIG. 35 illustrates another variation ablation stick 1505′ that issimilar to that of FIG. 28A except that the proximal shaft portion 1524′includes a housing 1720 that carries first and second stored energycomponents, 1725A and 1725B, that again can comprise one or morebatteries, capacitors or super capacitors. In this variation, thehousing 1720 also can carry a controller microchip 1740 for controllingenergy delivery from the stored energy components, 1725A and 1725B,during operation. In the ablation stick 1505′ shown in FIG. 35, thefirst stored energy component 1725A is adapted to deliver energy to theinterior chamber 1515′ to provide the subcritical liquid therein. Thesecond stored energy component 1725B is configured to be actuated todeliver electrical energy to the electrode arrangement about the flowoutlet 1720′ to thereby ionize the media flow exiting the flow outlet1420′ as described previously (see FIGS. 26A-27). The proximal portionof the ablation stick 1505′ also can carry one or more actuators orswitches (not shown) coupled to the controller microchip 1740 and/or thestored energy components, 1725A and 1725B to actuate the system for usein a procedure.

The 36 illustrates the ablation stick of FIG. 35 in preparation for usewhen at least one of the stored energy components, 1725A and 1725B, suchas a capacitor or super capacitor, is charged by a base station 1745 inwhich the ablation stick is docked. As can be seen in FIG. 36, theablation stick 1505′ may be housed for convenience and safety in a thinprotective sheath 1750. The base station or docking station 1745 canfurther include indicators, such as LEDs 1752 a and 1752 b, thatindicate whether the first and second stored energy sources 1725A and1725B are charging or have a complete charge and thus the probe is readyfor use in a medical procedure. It should be appreciated that such adocking station 1745 can have from 1 to 10 or more spaces for docking anablation stick as a medical procedure may require more than one ablationstick to complete the procedure.

While various treatments have been described above in ablating nerves,malignant tissue, hemorrhoids and scar tissue, it should be appreciatedthat the method of the invention includes the treatment of any tissue ina patient's body including tissues of a sinus, a nasal passageway, anoral cavity, a blood vessel, an arteriovascular malformation, a heart,an airway, a lung, a bronchus, a bronchiole, a lung collateralventilation pathway, a larynx, a trachea, a Eustachian tube, a uterus, avaginal canal, cervical tissue, a fallopian tube, a liver, an esophagus,a tongue, a stomach, a duodenum, an ileum, a colon, a rectum, a bladder,a prostate, a urethra, a ureter, a vas deferens, a kidney, a gallbladder, a pancreas, a bone, an interior of a bone, a joint capsule, atumor, a plexus of dilated veins, a fibroid, a neoplastic mass, braintissue, skin, lymph nodes, adipose tissue, sweat glands, a keloid, scartissue, muscle tissue, epidermal tissue, connective tissue, hyperplastictissue, hypertrophic tissue, an ovary, a wart, a cyst, a cornea and aretina as examples.

Although particular embodiments of the present invention have beendescribed above in detail, it will be understood that this descriptionis merely for purposes of illustration and the above description of theinvention is not exhaustive. Specific features of the invention areshown in some drawings and not in others, and this is for convenienceonly and any feature may be combined with another in accordance with theinvention. A number of variations and alternatives will be apparent toone having ordinary skills in the art. Such alternatives and variationsare intended to be included within the scope of the claims. Particularfeatures that are presented in dependent claims can be combined and fallwithin the scope of the invention. The invention also encompassesembodiments as if dependent claims were alternatively written in amultiple dependent claim format with reference to other independentclaims.

Other variations are within the spirit of the present invention. Thus,while the invention is susceptible to various modifications andalternative constructions, certain illustrated embodiments thereof areshown in the drawings and have been described above in detail. It shouldbe understood, however, that there is no intention to limit theinvention to the specific form or forms disclosed, but on the contrary,the intention is to cover all modifications, alternative constructions,and equivalents falling within the spirit and scope of the invention, asdefined in the appended claims.

The use of the terms “a” and “an” and “the” and similar referents in thecontext of describing the invention (especially in the context of thefollowing claims) are to be construed to cover both the singular and theplural, unless otherwise indicated herein or clearly contradicted bycontext. The terms “comprising,” “having,” “including,” and “containing”are to be construed as open-ended terms (i.e., meaning “including, butnot limited to,”) unless otherwise noted. The term “connected” is to beconstrued as partly or wholly contained within, attached to, or joinedtogether, even if there is something intervening. Recitation of rangesof values herein are merely intended to serve as a shorthand method ofreferring individually to each separate value falling within the range,unless otherwise indicated herein, and each separate value isincorporated into the specification as if it were individually recitedherein. All methods described herein can be performed in any suitableorder unless otherwise indicated herein or otherwise clearlycontradicted by context. The use of any and all examples, or exemplarylanguage (e.g., “such as”) provided herein, is intended merely to betterilluminate embodiments of the invention and does not pose a limitationon the scope of the invention unless otherwise claimed. No language inthe specification should be construed as indicating any non-claimedelement as essential to the practice of the invention.

Preferred embodiments of this invention are described herein, includingthe best mode known to the inventors for carrying out the invention.Variations of those preferred embodiments may become apparent to thoseof ordinary skill in the art upon reading the foregoing description. Theinventors expect skilled artisans to employ such variations asappropriate, and the inventors intend for the invention to be practicedotherwise than as specifically described herein. Accordingly, thisinvention includes all modifications and equivalents of the subjectmatter recited in the claims appended hereto as permitted by applicablelaw. Moreover, any combination of the above-described elements in allpossible variations thereof is encompassed by the invention unlessotherwise indicated herein or otherwise clearly contradicted by context.

All references, including publications, patent applications, andpatents, cited herein are hereby incorporated by reference to the sameextent as if each reference were individually and specifically indicatedto be incorporated by reference and were set forth in its entiretyherein.

What is claimed is:
 1. A system for delivering thermal energy to atissue, the system comprising: a probe having an interior chambercontaining a volume of a conductive liquid; a first energy sourceconfigured to rapidly heat the conductive liquid to convert theconductive fluid into a subcritical conductive liquid; a valve in fluidcommunication between the interior chamber and a flow outlet, where thevalve comprises a closed configuration to seal the interior chamberduring heating of the conductive liquid and an open configuration thatejects the subcritical conductive liquid out of the flow outlet to thetissue; and a second energy source adapted to apply energy to thesubcritical conductive liquid at the flow outlet to ionize thesubcritical conductive liquid.
 2. The system of claim 1, furthercomprising a controller configured to control operation of the firstenergy source.
 3. The system of claim 2, wherein the controller includesan algorithm adapted to modulate the first energy source in applyingenergy to conductive liquid in the interior chamber to provide apre-selected fluid temperature.
 4. The system of claim 3, furthercomprising a temperature sensor adapted to send signals to thecontroller indicating the temperature of conductive liquid in theinterior chamber.
 5. The system of claim 2 wherein the controller isfurther configured to control operation of the second energy source. 6.The system of claim 1 wherein the value comprises a component that opensat a predetermined pressure in the interior chamber.
 7. The system ofclaim 1 wherein at least one of the first and second energy sources iselectrical.
 8. The system of claim 7 wherein at least one of the firstand second energy sources is powered by a stored energy component. 9.The system of claim 8 wherein the stored energy component is at leastone of a battery and a capacitor.
 10. The system of claim 9 wherein thestored energy component is carried within the elongate probe.
 11. Thesystem of claim 9 wherein the stored energy component is coupled to theelongate probe by a cable.
 12. The system of claim 1 wherein the probeincludes working end at the flow outlet.
 13. The system of claim 1wherein the second energy source is coupled to an electrode arrangementadapted to deliver energy to the flow proximate to the flow outlet. 14.The system of claim 1, where the volume of the interior chamber isbetween 0.005 ml and 5 ml.
 15. The system of claim 1 wherein thecontroller and first energy source are adapted apply energy to theconductive liquid in the interior chamber to reach a temperature of atleast 150° C.
 16. The system of claim 1 wherein the controller andsecond energy source are adapted apply pre-determined energy to the flowabout the flow outlet to ionize the flow.